Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04347005




Registration number
NCT04347005
Ethics application status
Date submitted
10/03/2020
Date registered
15/04/2020

Titles & IDs
Public title
The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
Secondary ID [1] 0 0
AR882-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cohort 1: AR882
Treatment: Drugs - Cohort 2: AR882
Treatment: Drugs - Cohort 3: AR882
Treatment: Drugs - Cohort 4: AR882
Treatment: Drugs - Cohort 5: AR882
Treatment: Drugs - Cohort 6: AR882 Food Effect
Treatment: Drugs - Cohort 7: AR882 Solid Oral Formulation
Treatment: Drugs - Cohort 8: AR882 in combination with allopurinol
Treatment: Drugs - Cohort 9: AR882 in combination with febuxostat

Experimental: AR882 (Dose A) -

Experimental: AR882 (Dose B) -

Experimental: AR882 (Dose C) -

Experimental: AR882 (Dose D) -

Experimental: AR882 (Dose E) -

Experimental: AR882 (Dose B) Solid Oral Formulation -

Placebo comparator: Placebo -

Active comparator: Allopurinol -

Active comparator: Febuxostat -


Treatment: Drugs: Cohort 1: AR882
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 2: AR882
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 3: AR882
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 4: AR882
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 5: AR882
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 6: AR882 Food Effect
Single dose of AR882 or matching placebo in a fed state

Treatment: Drugs: Cohort 7: AR882 Solid Oral Formulation
Single dose of AR882 or matching placebo

Treatment: Drugs: Cohort 8: AR882 in combination with allopurinol
Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol

Treatment: Drugs: Cohort 9: AR882 in combination with febuxostat
Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
Timepoint [1] 0 0
8 Days
Primary outcome [2] 0 0
Safety Analyses
Timepoint [2] 0 0
8 Days
Primary outcome [3] 0 0
Safety Analyses
Timepoint [3] 0 0
8 Days
Primary outcome [4] 0 0
Safety Analyses
Timepoint [4] 0 0
8 Days
Primary outcome [5] 0 0
Safety Analyses
Timepoint [5] 0 0
8 Days
Primary outcome [6] 0 0
Safety Analyses
Timepoint [6] 0 0
8 Days
Primary outcome [7] 0 0
Safety Analyses
Timepoint [7] 0 0
8 Days
Primary outcome [8] 0 0
Safety Analyses
Timepoint [8] 0 0
8 Days
Primary outcome [9] 0 0
Safety Analyses
Timepoint [9] 0 0
8 Days
Primary outcome [10] 0 0
Safety Analyses
Timepoint [10] 0 0
8 Days
Primary outcome [11] 0 0
Safety Analyses
Timepoint [11] 0 0
8 Days
Primary outcome [12] 0 0
Safety Analyses
Timepoint [12] 0 0
8 Days
Primary outcome [13] 0 0
Area under the curve (AUC) for plasma AR882
Timepoint [13] 0 0
6 Days
Primary outcome [14] 0 0
Time to maximum plasma concentration (Tmax) for AR882
Timepoint [14] 0 0
6 Days
Primary outcome [15] 0 0
Maximum plasma concentration (Cmax) for AR882
Timepoint [15] 0 0
6 Days
Primary outcome [16] 0 0
Apparent terminal half-life (t1/2) for AR882
Timepoint [16] 0 0
6 Days
Primary outcome [17] 0 0
Amount excreted (Ae) into urine for AR882
Timepoint [17] 0 0
6 Days
Primary outcome [18] 0 0
Fractional Excretion (FEUA) for AR882
Timepoint [18] 0 0
6 Days
Secondary outcome [1] 0 0
PD profile of a single dose of AR882
Timepoint [1] 0 0
6 Days
Secondary outcome [2] 0 0
PD profile of a single dose of AR882 in combination with allopurinol
Timepoint [2] 0 0
6 Days
Secondary outcome [3] 0 0
PD profile of a single dose of AR882 in combination with febuxostat
Timepoint [3] 0 0
6 Days

Eligibility
Key inclusion criteria
* Serum uric acid level = 4.5 mg/dL (268 µmol/L)
* Body weight no less than 50 kg and body mass index (BMI) within the range of =18 and =33 kg/m2
* Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* History and/or presence of drug addiction or excessive use of alcohol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2019
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty, Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arthrosi Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04347005